Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Each gram contains betamethasone dipropionate, USP 0.64 mg equivalent to betamethasone, 0.5 mg. Betamethasone dipropionate ointment USP, 0.05% is supplied as: NDC 72578-093-01 in tube of 15 g NDC 72578-093-06 in tube of 45 g Storage: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light and freezing. Call your doctor for medical advice about side effects. You may report side effects to Viona Pharmaceuticals Inc. at 1-888-304-5011 or FDA at 1-800-FDA-1088.; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Betamethasone dipropionate ointment USP, 0.05% 15 gm NDC 72578-093-01 Rx only image image
- HOW SUPPLIED Each gram contains betamethasone dipropionate, USP 0.64 mg equivalent to betamethasone, 0.5 mg. Betamethasone dipropionate ointment USP, 0.05% is supplied as: NDC 72578-093-01 in tube of 15 g NDC 72578-093-06 in tube of 45 g Storage: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light and freezing. Call your doctor for medical advice about side effects. You may report side effects to Viona Pharmaceuticals Inc. at 1-888-304-5011 or FDA at 1-800-FDA-1088.
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Betamethasone dipropionate ointment USP, 0.05% 15 gm NDC 72578-093-01 Rx only image image
Overview
Betamethasone dipropionate ointment contains betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for dermatologic use. Betamethasone, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Betamethasone dipropionate is a white to cream white powder. It is practically insoluble in water, sparingly soluble in ethanol (96%) and freely soluble in acetone, in methylene chloride and in chloroform. Chemically, it is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21- dipropionate. The structural formula is: Each gram of the 0.05% ointment contains 0.64 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone) in an ointment base of mineral oil and white petrolatum. Image
Indications & Usage
Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Dosage & Administration
Apply a thin film of betamethasone dipropionate ointment to the affected skin areas once daily. In some cases, twice daily dosage may be necessary. If an infection develops, appropriate antimicrobial therapy should be instituted. Betamethasone dipropionate products should not be used with occlusive dressings.
Warnings & Precautions
No warnings available yet.
Contraindications
Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
Adverse Reactions
The following local adverse reactions are reported infrequently when betamethasone dipropionate products are used as recommended in the DOSAGE AND ADMINISTRATION section. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infections, skin atrophy, striae and miliaria. Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia and glucosuria in some patients.
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